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A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

Trial Information

A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

Inclusion Criteria:

- Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
to either imatinib or dasatinib

Type of Study:

Study Design:

Outcome Measure:

Rate of Major Molecular Responder (MMR) by BCR-ABL RQ-PCR analysis from peripheral blood by 12 months

Outcome Description:

Newly diagnosed Ph+ CML chronic phase (CP) patient will be counted as Major Molecular Responder (MMR) by 12 months if MMR criteria is achieved at least once any time between first study drug intake and cycle 12 visit.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

European Union: European Medicines Agency

Study ID:

CAMN107A2203

NCT ID:

NCT01844765

Start Date:

June 2013

Completion Date:

October 2016

Related Keywords:

Leukemia

Leukemia,Pediatric

Leukemia, Myleiod

Leukemia, Mylegenous, Chronic

Leukemia, Mylegenous, Accelerated

BCR-ABL Positive

Myeloproliferative Disorder

Bone Marrow Disease

Hematologic Diseases

Neoplastic Processes

Imatinib

Dasatinib

Enzyme Inhibitor

Protein Kinase Inhibitor

Tasigna

nilotinib treatment

chronic phase

Ph+ CML

accelerated phase

newly diagnosed Ph+ CML

pediatric

24 month treatment

Bone Marrow Diseases

Hematologic Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Neoplastic Processes

Name

Location

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